The following data is part of a premarket notification filed by Teledyne Water Pik with the FDA for Denar Accuceph Cephalometer Imaging System.
| Device ID | K944162 |
| 510k Number | K944162 |
| Device Name: | DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM |
| Classification | Cephalometer |
| Applicant | TELEDYNE WATER PIK 1730 EAST PROSPECT RD. Fort Collins, CO 80525 -1310 |
| Contact | Cody Riley |
| Correspondent | Cody Riley TELEDYNE WATER PIK 1730 EAST PROSPECT RD. Fort Collins, CO 80525 -1310 |
| Product Code | EAG |
| CFR Regulation Number | 872.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-26 |
| Decision Date | 1994-11-29 |